Phase 3 N=191 Randomized Quadruple-blind Prevention

NINDS CRC Chronic Migraine Treatment Trial

Chronic Migraine

Bottom Line

View on ClinicalTrials.gov: NCT00772031 ↗

Enrolled (actual)

191

Serious AEs

6.3%

Results posted

Jan 2012

Primary outcome: Primary: Change in the Number of Moderate to Severe Headache Days Within a 28 Day Average Period in Six Months Compared to Baseline — 4.4; 4.7 Moderate to severe headache days — p=0.77

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: propranolol LA (Drug); topiramate (Drug); placebo (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Anne Lindblad
Primary completion: Sep 2010

Outcome Measures

Outcome	Result	p-value
PRIMARY Change in the Number of Moderate to Severe Headache Days Within a 28 Day Average Period in Six Months Compared to Baseline	4.4; 4.7	0.77
SECONDARY Number of Subjects Experiencing at Least a 30% Reduction in 28-day Moderate to Severe Headache Days	37; 28	—
SECONDARY Number of Subjects Experiencing at Least a 50% Reduction in 28-day Moderate to Severe Headache Days	26; 23	—
SECONDARY Change From Baseline in Beck's Depression Inventory FastScreen Score at 6 Months	0.3; 0.6	—
SECONDARY Change From Baseline in Migraine Disability Assessment (MIDAS) Score at 6 Months	-3.18; -3.46	0.91
SECONDARY Change From Baseline in Migraine Specific Quality of Life (MSQ)-Role Restrictive Score at 6 Months	-0.7; -2.2	—
SECONDARY Change From Baseline in Migraine-Specific Quality of Life (MSQ)-Role Preventive at 6 Months	12.9; 5.9; -11.5; 11.0	—
SECONDARY Change From Baseline in Migraine-Specific Quality of Life (MSQ) - Emotional Function at 6 Months	8.9; 9.8	—

Summary

The purpose of this study is to compare the reduction in the number of severe headache days at six months in people with chronic migraine treated with topiramate and propranolol versus those treated with topiramate and a placebo.

Eligibility Criteria

Inclusion Criteria

History of chronic migraine for at least 6 months
Age ≥ 18 years and age of migraine onset 60 or younger
EKG performed in the last 12 months

Exclusion Criteria

Prior neuro-imaging suggesting secondary structural causes of headache
Beck Depression Inventory FastScreen score of 13 or greater or other severe psychiatric disorder
Contraindication to or prior intolerance of topiramate or propranolol (no history of sinus bradycardia, heart block, heart failure, diabetes prone to hypoglycemia, asthma, kidney stones)
History of kidney failure or nephrolithiasis
A female who is currently pregnant or lactating or planning to become pregnant in the next year, or is of child-bearing potential and not practicing an acceptable form of birth control
Currently requires butalbital or opioid drugs for acute headache treatment 10 or more days a month
Failure of prior trials with at least 50 mg of topiramate combined with at least 80 mg of propranolol
Use of other migraine preventive drugs (Medications graded as groups 1, 2, 3, and 4 in the AAN Evidence-based Guideline: valproate, divalproex sodium, gabapentin, amitriptyline, nortriptyline, protriptyline, beta-blocker, calcium channel blocker, cyproheptadine; and tizanidine) within the last two months or has received botulinum toxin injection in the past 3 months

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00772031). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.